PROTOCOLREVIEWANDMONITORINGSYSTEM PROJECTSUMMARY TheProtocolReviewandMonitoringSystem(PRMS)hasbeentheinternalreviewandmonitoringsystemfor allcancerclinicaltrialsconductedatYaleCancerCentersince1993.ThePRMSprovidesacentralized mechanismforevaluatingthescientificmeritofclinicaltrialsatYCC,andservesastheprimaryscientific reviewsystemforallcancer-relatedprotocolspriortoapprovalbytheYaleUniversityInstitutionalReview Board.ThePRMSSpecificAimsareto:1.ProvidescientificreviewoftheclinicaltrialsperformedattheYale CancerCenter;?2.SetprioritiesforclinicaltrialsattheYCCbasedonscientificmeritandportfolioprioritization;? 3.Reviewprogressofthetrialsforconductandaccrual.Thisgrantperiodhasseentherealizationofmany excitingPRMSaccomplishments,mostofwhichhavebeeninresponsetotheincrediblegrowthofcancer researchatYale,therenewedfocusontranslationalresearch,theunprecedentedrecruitmentofnewclinical researchfaculty,andtheexpansionoftheclinicaltrialsprogram.Selectedaccomplishmentsinclude: recruitmentofnewadministrativeleadershiptosupportthePRMS;?enhancedbiostatisticssupportwiththe formationoftheYaleCenterforAnalyticalScience(YCAS);?implementationoftheOnCoreClinicalTrials ManagementSystem(CTMS);?andrestructuringofourscientificprogressandaccrualreviewsystemwhichwill allowopportunitiesforextensionofstudiesintoSmilowCareCenters,affiliates,andcollaborationswithother institutions.Additionally,undersponsorshipoftheOfficeoftheYaleProvostandtheYCCDirector,the IMPACTconsultinggroupwasengagedtocompletelyreviewallaspectsoftheclinicalprotocolapprovaland activationprocessesatYaleUniversityinmid-2016,withthegoalofredesigningthebusinessprocesses necessarytomoveaprotocolfromtheconceptualstageatDARTreviewtothepointwhereitisopento accrualforpatients.Allstepsrelatedtoprotocolreviewandapproval,includingYCCcommittees,IRB, speciallyfocusedregulatorycommittees,budget,contracting,andEMRtemplating,weredissectedfor maximumefficiency.PriortoIMPACT,theexistingstaterequired33weeksmediantimetoprotocolactivation, withnumerousprocessesexistingoutsideYCCandwithoutoverallcoordination.Thenewlydesignedprocess formoreconcurrentupfrontreviewisbeingpilotedwith15studiesinearly2017.Thisprocesswillhavea centralofficetomanagetheoverallprocess,greaterpersonnel,andmoreconcurrentprocessestoreducethe activationtimeto18weeksorless.